Product Information for the User

Vaniqa 11.5% Cream

Eflornithine

Read this entire product information carefully before starting to use this medication, as it contains important information for you.

• Keep this product information. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.

1. How to use Vaniqa
2. Possible adverse effects

5Storage of Vaniqa

1. Contents of the package and additional information

Vaniqa contains the active ingredient eflornithine. Eflornithine slows down hair growth by affecting a specific enzyme (a protein in the body involved in hair formation).

Vaniqa is used to reduce excessive hair growth (hirsutism) on the face of women aged 18 years and above.

Do not use Vaniqa:

• if you are allergic to eflornithine or to any of the other ingredients of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Vaniqa

• inform your doctor about other medical conditions you may be experiencing (especially related to your kidneys or liver)

• if you are unsure about being able to use this medication, consult your doctor or pharmacist.

Excessive hair growth may be a sign of underlying diseases. Consult your doctor if you have polycystic ovary syndrome (PCOS) or hormone-producing tumors, or if you are taking medications that may induce hair growth, for example, ciclosporin (after organ transplantation), glucocorticoids (e.g. for rheumatic or allergic diseases), minoxidil (for hypertension), phenobarbital (for seizures), phenytoin (for seizures) or hormone replacement therapy with effects similar to male hormones.

Girls and adolescents

Vaniqais notrecommended for use in individuals under 18 years of age.

Other medications and Vaniqa

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those acquired without a prescription.

Consult your doctor if you need to use other medications on the skin areas where you are using the cream.

Pregnancy and breastfeeding

Do not use this medication if you are pregnant or breastfeeding. You should use an alternative method to treat your facial hair if you are pregnant or think you may be.

Driving and operating machines

No adverse effects on your ability to drive or operate machines are expected from Vaniqa.

Vaniqa contains cetearyl alcohol and stearyl alcoholwhich may cause local skin reactions (e.g. contact dermatitis).Vaniqa also contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216)which may cause allergic reactions(possibly delayed).

Follow exactly the administration instructions of this medication as indicated by your doctor.

In case of doubt, consult your doctor or pharmacist again.

• Use it twice a day, leaving a minimum of 8 hours between applications.
• If you experience irritation (e.g. stinging), reduce the use of Vaniqa to once a day until the irritation has passed. If it persists, contact your doctor.

• If you have shaved or used any other hair removal method, you must wait at least5 minutesbefore using Vaniqa. It may sting or burn if applied to cut or irritated skin.
• Clean and dry the areas of skin where you will apply the cream.
• Apply a thin layer of cream and spread it evenly by massaging until no visible residue of the product remains on the treated areas.

• Whenever possibledo notwash these areas of skin for the 4 hours following application of the cream.
• Wash your hands after applying the cream.
• Wait at least5 minutesbefore using makeup or sunscreen on the same areas.
• When using it on the face, avoidcontact with the eyes or the inside of the nose or mouth. If Vaniqa accidentally enters the eyes, mouth, or nose, rinse them well with water.

Vaniqais nota hair removal cream, so you may need to continue using your usual method of hair removal, for example shaving or waxing.

It may take up to 8 weeks for results to be visible. It is essential to continue using the cream. If you do not notice any improvement after using it for 4 months, consult your doctor. If you stop using it, your original hair growth may return in 8 weeks.

If you use more Vaniqa than you should

If too much cream is applied to the skin, it is unlikely to cause harm.

If you or someone ingests Vaniqa accidentally, inform your doctor.

If you forget to use Vaniqa

Apply it immediately, but wait at least 8 hours before using it again.

If you interrupt treatment with Vaniqa

To maintain the reduction of hair growth, continue using Vaniqa as directed.

If you have any other questions about using this product, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Side effects usually occur on the skin and are of mild intensity. In such cases, they usually resolve without interrupting treatment with Vaniqa.

The frequency of possible side effects listed below is defined using the following convention:

very frequent(affects more than 1 user in 10)

common(affects 1 to 10 users in 100)

infrequent(affects 1 to 10 users in 1,000)

uncommon(affects 1 to 10 users in 10,000)

very uncommon(affects fewer than 1 user in 10,000)

frequency not known(cannot be estimated from available data).

Very frequent (affects more than 1 user in 10)

1. acne

Common (affects 1 to 10 users in 100)

• dry skin
• hair loss
• inflammation around the pore
• itching
• skin rash
• redness
• skin irritation and bumps caused by shaving
• skin irritation

• sensation of burning, itching, or tingling of the skin

Infrequent (affects 1 to 10 users in 1,000)

• eruption with bumps (papular exanthema)
• cold sore
• redness and irritation at the site of cream application
• eczema
• inflamed, numb, cracked, or dry lips
• ingrown hairs
• skin discoloration
• skin bleeding
• cutaneous furuncles
• skin redness
• skin inflammation
• skin ulcers
• swelling of the mouth or face

1. abnormal texture of hair or abnormal hair growth

Uncommon (affects 1 to 10 users in 10,000)

• abnormal skin growth (skin neoplasia)
• excessive hair growth
• facial redness and acne possibly with pus
• other skin disorders
• inflammation and redness of the skin with peeling and itching (seborrheic dermatitis)
• eruption with redness, bumps, or blisters
• cutaneous cysts
• skin tightness

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do notuse this medication after the expiration date that appears on the packaging and on the bottom of the tube after CAD. The expiration date is the last day of the month indicated.

Once opened, discard the tube with remaining cream after 6 months.

Ensure the tube cap is closed perfectly after each use.

Do notstore at a temperature above 25 °C.

Medicationsshould notbe disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that are no longer needed. This will help protect the environment.

Composition of Vaniqa

The active ingredient is eflornithine.

Each gram of cream contains 115 mg of eflornithine (as monohydrate hydrochloride).

The other components are:

Cetearyl alcohol, cetearyl macrogol ether, dimethicone, glyceryl stearate, macrogol stearate, methyl parahydroxybenzoate (E218), liquid paraffin, phenoxethanol, propyl parahydroxybenzoate (E216), purified water, and cetearyl alcohol. In some cases, very small amounts of sodium hydroxide (E524) are added to maintain normal acidity levels (pH levels).

Appearance of the product and packaging size

Vaniqa is a white to off-white cream. It is available in 15 g, 30 g, and 60 g tubes, but not all presentations may be marketed.

Marketing Authorization Holder

Almirall, S.A.

Ronda General Mitre, 151

08022 Barcelona

Spain

Phone: +34 93 291 30 00

Manufacturer

Almirall Hermal GmbH

Scholtzstrasse 3

D-21465 Reinbek

Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder.

Last review date of this prospectus:

The detailed information about this medication is available on the European Medicines Agency website: http://www.ema.europa.eu